TriBEL Registry: National Belgian Registry of Percutaneous Tricuspid Valve Repair Using a Transcatheter Edge-to-edge Repair Technique

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-110
SponsorAZ Sint-Jan AV

About this trial

In this study, patients who have undergone or will undergo a transcatheter edge-to-edge repair (TEER) for tricuspid valve regurgitation (TR) will be followed up for 5 years. The goal of this prospective and retrospective, observational, non-randomized, multicenter registry is to confirm that TEER is a feasible, safe and effective treatment option for TR and to evaluate the long-term efficacy and safety of TEER.

The main endpoints are:

* Change in tricuspid regurgitation grade: number of patients with a reduction in tricuspid regurgitation score by at least one grade * Composite of major adverse event: number of patients with composite of major adverse event (cardiovascular mortality, acute kidney injury, myocardial infarction, stroke or TIA, coronary revascularization, new onset AF or ventricular arrhythmia)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

At least 18 years old

Eligible for TEER procedure

Informed consent signed

Disqualifiers

Unwilling to provide informed consent

Trial population

Patients with tricuspid valve regurgitation eligible for transcatheter edge-to-edge repair

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Transcatheter edge-to-edge repair (TEER)

    Procedure/Surgery

    Minimally invasive transcatheter-based edge-to-edge repair technique for tricuspid regurgitation

Treatment groups

120 Participants
are divided into 1 treatment group
Group A: TEER1 intervention

Trial outcomes

Primary outcomes

1

Number of patients with a reduction in tricuspid regurgitation score by at least one grade

Number of patients with a reduction in tricuspid regurgitation score by at least one grade 30 days post-procedure

Time frame
30 days
2

Composite of major adverse event

Number of patients with composite of major adverse event (cardiovascular mortality, acute kidney injury, myocardial infarction, stroke or TIA, coronary revascularization, new onset AF or ventricular arrhythmia)

Time frame
1 year

Secondary outcomes

1

Number of patients with a reduction in tricuspid regurgitation score by at least one grade at 6 months post-procedure

Number of patients with a reduction in tricuspid regurgitation score by at least one grade 6 months post-procedure

Time frame
6 months
2

Number of patients with a reduction in tricuspid regurgitation score by at least one grade 1 year post-procedure

Number of patients with a reduction in tricuspid regurgitation score by at least one grade 1 year post-procedure

Time frame
1 year
3

Number of patients with a reduction in tricuspid regurgitation score by at least one grade 2 years post-procedure

Number of patients with a reduction in tricuspid regurgitation score by at least one grade 2 years post-procedure

Time frame
2 years
4

Number of patients with a reduction in tricuspid regurgitation score by at least one grade 3 years post-procedure

Number of patients with a reduction in tricuspid regurgitation score by at least one grade 3 years post-procedure

Time frame
3 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: